Sr. Data Manager
Senior Data Manager - Clinical Research Management Office (CRMO)
The Clinical Research Management Office (CRMO) provides administrative, nursing, and data management support for cancer treatment clinical trials conduced by Lombardi Investigators. This includes all regulatory documents, IRB submissions, budget and contract negotiations, consenting of subjects, case management of patients while on study, side effect management, completion of case report forms, meeting with monitors, maintaining trial information on Lombardi website, design of electronic case report forms for institutional trials.
The Senior Data Manager has the responsibility of managing the data of complex clinical trials portfolios and ensures that data collection is accurate and on time. Duties include but are not limited to:
- Coordinates and organizes the data entry, data locks, monitoring and audit deadlines in their disease group team for complex clinical trial portfolios.
- Manages query resolution in a timely manner and appropriate communication with study team and sponsor.
- Oversees prioritization of studies of high importance (e.g. high accrual, Phase I, data locks, audits, etc.) for data disease group team.
- Assists data disease team to prepare for and participate in internal and external audits.
- Trains and mentors data disease team in prioritizing deadlines. Communicates study status, timeline updates and data deadlines to supervisor.
- Trains and mentors data disease group team on good clinical and research practices, process and regulations in compliance with standard operating procedures.
- Accountable for managing diverse assignments and mentoring other staff as needed for fast accruing studies.
- Works with supervisor in maintaining SOPs, staying up to date with current GCP regulations and continuous process improvement initiatives.
- Collaborates with QA manager and DM supervisor to identify areas of education and quality improvement.
- Bachelor‘s degree; Master's Degree in a Science related field preferred
- 5+ years of clinical research experience
If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Please select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.
Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.
If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or email@example.com.
Need some assistance with the application process? Please call 202-687-2500
Georgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex, disability status, protected veteran status, or any other characteristic protected by law.